Atlas

Form 483

CATALENT U.K. SWINDON ZYDIS LIMITED Form 483, 2014-09-12

FDA issued a Form 483 to CATALENT U.K. SWINDON ZYDIS LIMITED on 2014-09-12 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

CATALENT U.K. SWINDON ZYDIS LIMITED · Swindon, United Kingdom · Issued September 12, 2014

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

12 Sep 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Nicholas L Paulin

12 Sep 2014
21 CFR 211.28(a)

Protective Apparel Not Worn

Cited by Nicholas L Paulin

12 Sep 2014
21 CFR 211.68(a)

Written calibration / inspection records not kept

Cited by Nicholas L Paulin

12 Sep 2014
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Nicholas L Paulin

Inspected site

CUCATALENT U.K. SWINDON ZYDIS LIMITEDSwindon, United Kingdom

Inspection team

NLNicholas L Paulin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere